News & Analysis as of

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Goodwin

FDA Approves BMS and J&J CAR-T Cell Therapies for the Earlier Treatment of Multiple Myeloma

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On April 4, 2024, Bristol Myers Squibb (“BMS”) and 2seventy bio, Inc. announced that the FDA has approved ABECMA (idecabtagene vicleucel) for the treatment of adult patients with relapsed or refractory multiple myeloma after...more

Goodwin

FDA Approves New Indication for AstraZeneca and Daiichi Sankyo’s Cancer Drug ENHERTU

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​​​​​​​On April 5, the FDA granted accelerated approval to AstraZeneca and Daiichi Sankyo’s ENHERTU (trastuzumab deruxtecan) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have...more

Fish & Richardson

Biologics and Biosimilars Landscape: IP, Policy, and Market Developments

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In this review, we discuss the most important recent developments in the biosimilars space, including new biosimilar approvals and launches, litigation under the Biologics Price Competition and Innovation Act (BPCIA),...more

Goodwin

FDA Approves First Gene Therapy to Treat Children with Metachromatic Leukodystrophy

Goodwin on

On March 18, 2024, the FDA approved Orchard Therapeutics’ LENMELDY, the first approved gene therapy for the treatment of children with metachromatic leukodysrophy (MLD)....more

Shearman & Sterling LLP

Northern District Of California Court Partially Grants Motion To Dismiss Putative Securities Class Action Against Pharmaceutical...

On March 11, 2024, Judge Haywood S. Gilliam, Jr. of the United States District Court for the Northern District of California granted in part and denied in part a motion to dismiss a putative securities class action brought...more

Goodwin

Celltrion Announces Commercial Availability of ZYMFENTRA™ (infliximab-dyyb)

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Celltrion USA announced on March 18, 2024, the availability of ZYMFENTRA™ (infliximab-dyyb), a subcutaneous (SC) formulation of infliximab…...more

Venable LLP

The First Prolia® / Xgeva® Biosimilar Approvals in the U.S.

Venable LLP on

On March 5, 2024, the FDA approved Sandoz’s Jubbonti® and Wyost® (denosumab-bddz) as the first biosimilars of Amgen’s Prolia® and Xgeva® (denosumab). The launch date for these biosimilars has not been announced as Amgen and...more

Goodwin

Fresenius Kabi Announces FDA Approval of TYENNE, a Tocilizumab Biosimilar Referencing ACTEMRA

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​​​​​​​On March 7, Fresenius Kabi announced that the FDA has approved its tocilizumab biosimilar, TYENNE (tocilizumab-aazg) for inflammatory and immune diseases indications including rheumatoid arthritis, giant cell...more

Venable LLP

Fresenius Kabi’s Actemra® biosimilar Tyenne® (tocilizumab-aazg) Approved in the U.S.

Venable LLP on

On March 5, 2024, the FDA approved Fresenius Kabi’s Tyenne® (tocilizumab-aazg) as a biosimilar of Chugai, Genentech and Hoffman-La Roche’s Actemra® (tocilizumab). ...more

McDonnell Boehnen Hulbert & Berghoff LLP

FDA Approves Three Interchangeable Biosimilar Drugs in 2024

After taking most of a decade to approve its first interchangeable biosimilar (Semglee (insulin glargine-yfgn), the U.S. Food and Drug Administration has approved three interchangeable biosimilars since the beginning of this...more

Goodwin

FDA Approves Sandoz Denosumab Biosimilars

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​​​​​​​On March 5, Sandoz announced that the FDA approved its denosumab biosimilars, WYOST and JUBBONTI, as interchangeable with Amgen’s XGEVA and PROLIA. These are the first and only FDA-approved denosumab biosimilars....more

Goodwin

Teva and Alvotech’s Adalimumab Biosimilar Receives Interchangeable Status at FDA

Goodwin on

On February 23rd, 2024, Alvotech and Teva announced FDA’s approval of SIMLANDI (adalimumab-ryvk), the first high-concentration and citrate-free biosimilar interchangeable with Humira. SIMLANDI injection was approved for nine...more

Mintz

Client Corner: Meet CEO and COO of Suono Bio, Scott Kellogg & Skip Farinha

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Mintz’s Client Corner: Perspectives from Founders, Financiers, and Friends podcast series hosted by Mintz Member Joshua Fox explores the challenges and rewards associated with starting and running a business and investing in...more

Venable LLP

First High-Concentration Humira® Interchangeable, Alvotech and Teva’s Simlandi®, Approved in the U.S.

Venable LLP on

On February 23, 2024, the FDA approved Alvotech and Teva’s Simlandi® (adalimumab-ryvk) as biosimilar to and interchangeable with AbbVie’s Humira® (adalimumab). Simlandi® is the tenth Humira® biosimilar to be approved, and the...more

Polsinelli

FDA 2023-24: A Look Back & A Peek Forward

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Most years are eventful for businesses regulated by the US Food and Drug Administration (“FDA”), and 2023 was no exception. 2024 promises more of the same – it being a Presidential election year, some FDA decisions (increased...more

Goodwin

FDA Approves First Cellular Therapy for Treatment of Unresectable or Metastatic Melanoma

Goodwin on

​​​​​​​On February 16, 2024, the FDA approved Iovance’s AMTAGVI, the first approved cellular therapy for the treatment of adult patients with unresectable or metastatic melanoma....more

Goodwin

FDA Approves XOLAIR to Treat Children and Adults With One or More Food Allergies

Goodwin on

​​​​​​​Genentech announced on February 16, 2024, that the U.S. Food and Drug Administration (FDA) approved XOLAIR (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental...more

Jones Day

FDA on Board With Continuing Remote Inspections

Jones Day on

The Food and Drug Administration ("FDA") recently issued revised draft guidance on remote regulatory assessments ("RRAs")—voluntary or mandatory examinations of food, drug, device, and tobacco establishments and/or their...more

DRI

[Event] Drug and Medical Device Seminar - May 20th - 22nd, Washington, DC

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Join us in Washington D.C. for the Drug and Medical Device industry’s premier event for learning, networking, and advancing the defense of life sciences clients! You’ll hear from heads of litigation from the world’s foremost...more

Knobbe Martens

FDA Approves Edwards EVOQUE® Tricuspid Valve Replacement System

Knobbe Martens on

The U.S. Food and Drug Administration (“FDA”) recently approved the Edwards EVOQUE®  Tricuspid Valve Replacement System (the “EVOQUE® system”) for use in treating Tricuspid Regurgitation (“TR”). The EVOQUE®  system is...more

Hogan Lovells

U.S. device makers get 2 years to comply with FDA Quality Management System Regulations final rule

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) published its long-awaited final rule to amend the Quality System Regulation’s (QSR’s) current good manufacturing practice (CGMP) requirements for medical devices. The final rule...more

Knobbe Martens

Deep Brain Simulation Devices Market Expected to Reach USD 3.5 Billion by 2033

Knobbe Martens on

A recent paper published by market.us projects that the Deep Brain Stimulation (DBS) devices market is expected to reach around $3.5 Billion by 2033, compared to the projected $1.5 Billion for 2024....more

Snell & Wilmer

Regulatory Matters – FDA Updates Emergency Use Authorization for Paxlovid

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A little over two years ago, the FDA authorized Paxlovid for emergency use for the treatment of adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe...more

Goodwin

Celltrion Launches 80 mg YUFLYMA (adalimumab-aaty) in the U.S.

Goodwin on

On January 17, 2024, Celltrion announced the U.S. launch of a new, 80 mg/0.8 ml dosage strength of its HUMIRA® biosimilar, YUFLYMA® (adalimumab-aaty). As we previously reported, Celltrion received FDA approval for an 80...more

Goodwin

Year in Review: Top Regulatory Developments of 2023

Goodwin on

​​​​​​​As we kick off 2024, we reflect on regulatory developments in the biologics and biosimilars space in 2023. Below are some of the top regulatory developments from 2023....more

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JD Supra Privacy Policy

Updated: Dec 28, 2021:

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Information for EU and Swiss Residents

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Privacy Officer
JD Supra, LLC
150 Harbor Drive, #2760
Sausalito, CA 94965

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Privacy Officer
JD Supra, LLC
150 Harbor Drive, #2760
Sausalito, CA 94965

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Updates to This Policy

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

Contacting JD Supra

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